The EC published a revised version of annex 15 which will come in effect as of October 1st 2015. The chapter has been extended from 11 to 16 pages and specifically mentions that retrospective validation is no longer considered an acceptable approach. Other changes include an extended content of the Validation Master Plan (VMP), the possibility to combine installation (IQ)/ operation (OQ) qualifications as a single IOQ document, and the statement that the acceptance criteria “visibly clean” as a single acceptance criteria is no longer accepted.

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